Irrigation and aspiration device and method

ABSTRACT

An irrigation and aspiration system is disclosed. The system can be configured to aspirate and irrigate alone, sequentially or concurrently. The system can be configured to aspirate and irrigate the nasal cavity. The system can be manually controlled. The system can have removable and easily cleanable reservoirs for aspirant and irrigant.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 13/080,093 filed Apr. 5, 2011, which is acontinuation of U.S. patent application Ser. No. 11/936,042, filed Nov.6, 2007 (now U.S. Pat. No. 7,959,597 issued on Jun. 14, 2011), whichclaims priority to U.S. Provisional Application No. 60/857,457, filedNov. 6, 2006, and U.S. Provisional Application No. 60/944,079, filedJun. 14, 2007, all of which are incorporated by reference herein intheir entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the field of medicine, specificallynasal aspiration and irrigation, as administered in the hospital as wellas in the home. In particular, the device may be able to aspirate andirrigate simultaneously through one nozzle. Both actions can becontrolled by one dual-function switch.

2. Description of Related Art

Nasal congestion is a ubiquitous problem in children and adults. Viralillnesses and environmental allergies in about 100 million Americans peryear cause myriad symptoms including rhinitis (i.e., nasalinflammation), which causes congestion, rhinnorhea, and sinus blockage.This can cause sinusitis, but more commonly, irritation, pain, and nasalcavity blockage, which causes poor sleeping and feeding in infants andgeneral discomfort and malaise in adults. Medical treatments areavailable, but inherently have side effects and financial costs. Reliefof congestion can be met by blowing the nose, which is eventuallyirritating to the adult and difficult or impossible for a child orinfant.

It has been shown that nasal suctioning, following saline irrigation, isan effective way of relieving symptoms and signs of rhinitis. Nasalsuctioning can circumvent the side effects of medicines andirritation—or impossibility—of nose blowing. Manual aspirators have longbeen used in infants for this. However, they do not offer strong enoughvacuum nor adequate evacuation time. As a result, they are variablyefficacious and can be awkward and frustrating to use. Typical sinusirrigators designed for adults with sinusitis do not circumvent theproblem of painful evacuation or blowing.

Furthermore, nasal congestion from viral respiratory infections causesdifficulties with sleeping and eating in infants as they are obligatenose breathers. This leads to poor nutrition and restlessness whichdisrupts both the child's well being and the family's functioning.Worse, unresolved nasal congestion as part of an infant's viral syndromecan lead to emergency department visits or hospitalization forsupplemental oxygen, frequent suctioning, and parenteral nutrition.

Several strategies are used to resolve nasal congestion. Several studieshave demonstrated futility of cold medications in relieving symptoms,and most parents learn that nasal irrigation and suctioning is the bestoption. Routine nasal irrigation improves symptoms in adults withchronic rhinosinusitis as well as children with allergic rhinitis.Additionally, several studies have shown that saline irrigation improvesnasal ciliary motility. It is thought that the saline draws fluid fromthe submucosal and adventitial space decreasing airway edema andsoftening the mucus, allowing easier suctioning. Additionally, thesaline is thought to stimulate channels in the cell membrane whichimproves the cell's function.

Such a combination of saline irrigation and suctioning has provenbenefits, especially for infants with bronchiolitis. Most studiesevaluating nasal suctioning used hospital's central “wall” suction andsome studies even used deep nasopharyngeal suctioning, both of which arenot routinely available for home use. The studies demonstrated thatappropriate suctioning reduces the need for further interventions, suchas nebulizations, oxygen supplementation and admissions.

In contrast to hospital wall suction, manual nasal aspirators areavailable for home use. Their maximal negative pressure and flow ratesare low, requiring repeated movements to and from the nose. Bothparameters contribute to their imperfect quality: more pressure has beenshown to be optimal (80-100 mmHg) and the short duration of their actionrequires repeated attempts back and forth rendering them awkward.)

Typical bulb suction syringes offer some suction, but brief andinadequate pressures can limit its utility. Additionally, the narrow andlong stem allow for the possibility of mucosal damage as well as aninadequate seal at the nares. Some manual aspirators have circumventedthat problem by developing better nasal tips that have improved seal andsafety.

An existing manual device can sequentially (not simultaneously) deliveran agent followed by aspiration of the agent and orifice contents. Itallows for neither the simultaneous activation of both functions nor thehigher vacuum/flow as with a motorized device.

Still other devices have dual actions, though not designed for nasalcavities and not all-contained. For example, a hand-piece exists forsurgical aspiration and irrigation. It is for surgical purposes(celioscopy) and not a home device. It requires outside sources of bothvacuum and irrigant and can only perform one action at a time.

Another device describes a system for irrigating and aspirating surgicalwounds. It consists of an elongate flexible suction and irrigation tipas opposed to our nozzle head configuration. The flexible shaft has asuction lumen next to or inside an irrigation lumen. The triggercontrols only the irrigation mechanism while an outside source providesconstant, and not intermittent, suction.

U.S. Pat. No. 4,776,840 is a hand-held evacuator and irrigation devicealso for surgical purposes only. Its sources of vacuum and irrigant arealso outside the housing, and needs two buttons to operate the twofunctions. The two functions are also delivered by two different ports,not one.

U.S. Pat. No. 5,649,530 discloses a nasal cleaning device that had anatomizing chamber within the nozzle and a chamber for collectingaspirant proximal to the chamber. The aspirant and irrigant can mixtogether within the nozzle. This can result in unsanitary irrigantdelivered to the nose.

Finally, U.S. Pat. No. 6,893,414 is an integrated infusion aspiratordevice also used for surgical procedures specifically addressingpost-surgical pain by cleaning out surgical wounds. It allows forconcurrent irrigation and aspiration of wound sites for any internalbody wound. It also relies on outside sources of vacuum and irrigant.

SUMMARY OF THE INVENTION

A self-contained motorized device that offers a continuous orintermittent suction as well as a continuous or intermittent on-demandirrigant delivery to the nasal passages is disclosed. The suction andthe irrigant deliver can both be out of the same nozzle. The suction andirrigation can be actuated by an ergonomically designed dual functionswitch. The device can have a removable irrigant and/or suction module.

A device for irrigating and aspirating biological tissue and/orsecretions is disclosed. The device has a body, a nozzle articulatablyconnected to the body, an electronically driven fluid control system,and a manual control. The manual control can be configured to controlthe fluid control system. The fluid control system can be contained inthe body. The fluid control system can be configured to irrigate at anirrigation pressure and aspirate at an aspiration pressure

The device can also have a head articulatably connected to the body. Thenozzle can be on the head. The head can be attached to the body. Thefluid control system can be configured to simultaneously irrigate andaspirate. The fluid control system can be configured to vary theirrigation pressure at more than one non-zero pressure. The fluidcontrol system can be configured to vary the pressure of aspiration atmore than one non-zero pressure.

The manual control can control irrigation and aspiration. The manualcontrol can be configured to be usable with a single digit (e.g., fingeror thumb). The entire device can be handheld. The body can have a powersource. The body can have a first motor.

The device can have a pump. The pump can have a piston, a blower, aturbine, a fan, one or more diaphragms, or bellows, or combinationsthereof. The pump can be electrically powered. The pump can be a DCpump.

The fluid control system can have a first reservoir having a firstreservoir volume. The first reservoir can be removably attached to thebody. The first reservoir can have an irrigant. The fluid control systemcan have a second reservoir having a second reservoir volume. The secondreservoir can be removably attached to the body. The second reservoircan have an aspirate. The second reservoir volume can be the same sizeas, smaller, or larger than the first reservoir volume.

The control can have a button. The button can be translatable in morethan one dimension. The button can have a slide. The button can have arocker switch. The button can have a wheel. The button can bedepressible. The button can be configured to provide aspiration andirrigation control.

The device can have an aspiration conduit and an aspiration port influid communication with the aspiration conduit. The aspiration port canbe on or in the head.

The device can have an irrigation conduit and an irrigation port influid communication with the irrigation conduit. The irrigation port canbe on or in the head.

A method for irrigating and aspirating the nose is also disclosed. Themethod can include simultaneously irrigating at an irrigation pressureinside the nose with a device and aspirating at an aspiration pressureinside the nose with the device. The method can also include separatelycontrolling the irrigation and aspiration with a button.

The separately controlling can include using a digit. The simultaneouslyirrigating and aspirating can include varying the irrigation pressurebetween non-zero irrigation pressures. The simultaneously irrigating andaspirating can include varying the aspirating pressure between non-zeroaspiration pressures.

The device can have a body connected to a head, and the method caninclude articulating the head with respect to the body. The method caninclude holding the entire device in a hand.

The method can also include storing in the device a fluid to beirrigated. The method can also include storing in the device a fluidaspirated from the nose.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a variation of the irrigation and aspiration device.

FIG. 2 is a cut-away schematic view of a variation of the of theirrigation and aspiration device.

FIG. 3 is a cut-away view of a variation of the head.

FIG. 4 is a partially see-through view of a variation of the head.

FIG. 5 is a partially see-through cut-away view of the variation of thehead of FIG. 4.

FIG. 6 is a cut-away view of a variation of the head.

FIG. 7 is a cut-away view of a variation of the bead.

FIG. 8 is a close-up cut-away view of the variation of the head of FIG.7.

FIG. 9 is a close-up end perspective view of a variation of theirrigation and atomizing conduits.

FIG. 10 is a perspective partially see-through view of a variation ofthe head and the irrigation conduit.

FIG. 11 is a front quarter partially see-through view of the variationof the head and the irrigation conduit of FIG. 10.

FIGS. 12 and 13 are, respectively, side and off-center front partialsee-through views of the head of FIG. 10.

FIG. 14 illustrates an end perspective view of a variation of the head.

FIGS. 15 and 16 illustrate variations of the head.

FIGS. 17 and 18 are cut-away views of a variation of the head in firstand second configurations, respectively.

FIG. 19 is a cut-away view of a variation of the head.

FIG. 20 is a cut-away view of a variation of the irrigation andaspiration device.

FIG. 21 is a partially see-through view of a variation of the irrigationand aspiration device.

FIG. 22 is a cut-away view of a variation of the aspiration component ofthe irrigation and aspiration device.

FIGS. 23 and 24 are isometric and side partial cut-away views of avariation of the irrigation and aspiration device.

FIGS. 25 and 26 are side and front views of the irrigation andaspiration device of FIGS. 23 and 24.

FIGS. 27 and 28 illustrate various methods for filling the irrigationand aspiration device with irrigant.

FIG. 29 is a cut-away view of a variation of the irrigation andaspiration device.

FIG. 30 is a partial cut-away view and partial schematic diagrams of avariation of the irrigation and aspiration device.

FIG. 31 is partial cut-away view and partial schematic diagrams of avariation of the irrigation and aspiration device.

FIG. 32 is partial cut-away view, partial see-through view and partialschematic diagrams of a variation of the irrigation and aspirationdevice.

FIG. 33 illustrates a variation of the irrigation and aspiration device.

FIGS. 34a-c are isometric, top and side views, respectively, of avariation of a dual diaphragm pump.

FIGS. 35 through 37 illustrate a variation of a method of using avariation of the irrigation and aspiration device.

FIG. 38 illustrates a variation of a method of using a variation of theirrigation and aspiration device.

FIGS. 39, 40, 41 and 44 are schematic diagrams of a variation of theirrigation and aspiration device in various configurations.

FIGS. 42 and 43 are schematic drawings of a variation of the first valveand the surrounding channels of FIG. 41 in first and secondconfigurations, respectively.

FIGS. 45 through 47 illustrate a distal portion of a variation of theirrigation and aspiration device showing the articulating neck invarious configurations.

FIG. 48 illustrates a variation of a method of using a variation of theirrigation and aspiration device with the articulating neck.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate a cleaning device 2 or system for irrigationand/or aspiration of biological tissues or fluids. The device 2 can beused in a body cavity, such as the nasal cavity, the mouth and/orthroat, the ear, the eye, a skin fold, the bellybutton, a wound, orcombinations thereof. The device 2 can be inserted into a natural bodyorifice (i.e., a normal physiological orifice, such as a nostril,mouth—including access to the throat, esophagus, stomach and lungs—earcanal, eye, naval, rectum, urethra, vagina, or adipose or fat fold), awound, a surgical device (e.g., surgery port), or combinations thereof.The device 2 can be configured to perform nasal aspiration and/or nasalirrigation alone, sequentially or simultaneously. Aspiration can includesuctioning. The device 2 can be configured to irrigate and suctionconcurrently. The device 2 can have an automatically driven vacuum and amanually actuated irrigation, both of which can operate simultaneously.

The device 2 can have a body 4. The body 4 can encase a power source 6or supply. The body 4 can be connected to an external power source 6(e.g., via a power cord). The body 4 can have a fluid control system.The fluid control system can have a driving motor. The fluid controlsystem can have a pump 8. The pump 8 can be manual or automatic (e.g.,AC or DC electrically powered). The pump 8 can be or have a piston pump,a blower, a turbine, a fan, a diaphragm pump or combinations thereof.The motor can be part of the pump 8. The fluid control system can havevalves 10 that can be configured to control the flow of fluid within thefluid control system.

The outer wall as well as internal portions of the body 4 can be madefrom a plastic, for example ABS, polycarbonate, or a combinationthereof. The outer wall as well as internal portions of the body 4 canbe made by injection molding, for example by injection molding halvesand assembling.

The body 4 can be attached or integral with a neck 12. The neck 12 canbe attached or integral with a head 14. The neck 12 can be attached tothe body 4 at a neck connector 16. The neck connector 16 can be a screw,snap, press fit connector, or combinations thereof. The neck 12 can be aflexible or rigid connection between the head 14 and the body 4.

The head 14 can be directly, or via the neck 12, attached or integralwith the body 4. The head 14 can be positioned at varying anglesrelative to the body 4. The head 14 can articulate freely relative tothe body 4 (e.g., handle). The body 4 can be held in the user's hand.The connections of the head 14 to the body 4 can be compliant andflexible so as the head 14 can pivot and translate from the perimeter ofthe head 14 (this is stated for exemplary purposes only, there aremultiple mechanical solutions).

The neck 12 can be articulatable (e.g., pivotable, otherwise rotatable,translatable). The neck 12 can be freely articulatable, can articulateat fixed, stepped angles, or combinations thereof. For example, the neck12 can have gussets or ribs configured to allow the head 14 to rotatewith respect to the body 4.

The components within the neck 12 can be configured to rotate with theneck 12. For example, as shown in FIG. 2, an aspirant pressure line 18,atomizing channel 20 (or atomization channel), and irrigant pressureline 22 can be flexible and extendable. The irrigant channel 24 (e.g.,at the irrigant pressure line 22), atomization channel 20, and aspirantchannel 26 (e.g., at the aspirant pressure line 18) can each have are-attachable division or split therein. The re-attachable division canconnect in a male-female manner, such as a screw fit, snap fit, pressfit, or combinations thereof. The re-attachable division can, forexample, enable the head 14 to be removed from the body 4 while removingpart of the channels with the head 14 and while leaving the remainingportion of the channels attached to or integral with the body 4. There-attachable division or split can also enable rotation and translationalong the channels between the head 14 and the body 4.

The body 4 can have grip pads 28. The grip pads 28 can have soft rubber.The grip pads 28 can be attached and/or integral with the body 4. Thegrip pads 28 can be ergonomically located about the body 4. The grippads 28 can be configured to be located at all or some of the locationswhere the user (e.g., the user's palm) naturally applies pressure to thebody 4 during use.

The body 4 can have various colors, transparent, translucent, and/oropaque materials, and/or lights, for example for operational purposesand/or for entertainment of the user.

The device 2 can have a power source 6. The power source 6 can be storedcompletely or partially in a compartment, for example a batterycompartment. The battery compartment can be in the body 4. The powersource 6 can have one or more electrical cells (e.g., one or morebatteries). The power source 6 can have, for example, four AA alkalinebatteries in series. The power source 6 can produce 6 volts andapproximately 2,000 mAh. The power source 6 can connect to an externalsupply of electricity (e.g., a 120 V electrical wall outlet). Thebattery compartment can be accessible from outside of the body 4 througha battery compartment door 30. The battery compartment door 30 can beremovably attached to the body 4. The battery compartment door 30 can behingedly attached to the body 4.

The body 4 can have a power light (e.g., LED).

The one or more pumps 8 and valves 10 can be in fluid communication withan aspirant pressure line 18, and/or an atomizing channel 20 and/or anirrigant pressure line 22. The control 32 can be configured to managewhich valves 10 are open and closed, and/or how open and closed thevalves 10 are, and/or what pumps 8 are on or off and/or at what speed(e.g., flow rate and/or pressure) which pumps 8 operate. The pumps 8 andvalves 10 can create positive and/or negative pressures in the aspirantpressure line 18, and/or atomizing channel 20, and/or irrigant pressureline 22. The aspirant pressure line 18, and/or atomizing channel 20,and/or irrigant pressure line 22 can have individual inflow and outflowsub-channels into the pumps 8 and valves 10.

The device 2 can have a control 32. The control 32 can be configured toprovide multiple functions. The control 32 can enable user-induced,automated actuation of the device 2. For example, the control 32 canhave a dual function switch, or one or more multiple-function switches,or one or more single-function switches, or combinations thereof. Theswitch can have a button 34. The switch can be attached or integral withthe body 4, head 14, neck 12, or combinations thereof.

The control 32 can transmit power from the power source 6 to the pumps 8and valves 10. The control 32 can be configured to receive input fromthe one or more switches (e.g., the button 34). The control 32 cancontrol power delivery (e.g., electricity) from the power source 6 tothe pump 8 and valves 10. The control 32 can receive a first input, forexample the sliding translation of the button 34 or the pressingtranslation 38 of the button 34. The control 32 can receive a secondinput, for example the other of the sliding translation 36 of the button34 or the pressing translation 38 of the button 34 that is not the firstinput. The first input can control the aspiration, for example whetheraspiration is on or off and/or the intensity of the pressure and/or flowrate of aspiration. The second input can control the irrigation, forexample whether irrigation is on or off and/or the intensity of thepressure and/or flow rate of the irrigation.

The switch can have a single sliding button 34. The switch can beoperated by a single digit (i.e., finger 40 or thumb 42). One or moreswitches can control the aspiration (i.e., suction) and irrigation withone digit (i.e., finger 40 or thumb 42). The switch can be configured toreceive multiple input signals (e.g., from the user). The switch canhave one, two or more degrees of freedom. For example, the button 34 canreceive a pressing translation 38, as shown by arrow, and a slidingtranslation 36, as shown by arrows. The control 32, via the multipleinput signals (e.g., pressing and sliding), can be configured toseparately control (e.g., binary/two-state control (on/off) and/orvariable control of the magnitude of power to gradually increase ordecrease) the aspiration and the irrigation. For example, one inputsignal (e.g., sliding) can control the aspiration and another inputsignal (e.g., pressing) can control the irrigation. The sliding can bealong the longitudinal axis of the body 4, head 14 or neck 12. Thepressing can be orthogonal to the sliding.

The switch can be bi-functional. The switch can have a rocker platformthat can encase a variable speed switch. The switch can be moved from anoff setting to a maximum speed (and/or on/off) setting by sliding theswitch along the platform. The platform can be flush with, inside, oroutside the device 2 housing. The platform can be hinged 44 at a firstend and free at a second end. The platform can be resiliently pressedtoward the remainder of the device 2, for example, over a balancingspring. Pressing the platform can manually actuate, or activateautomatic actuation of, irrigation.

The pressing the pivoting switch housing can automatically actuateirrigation (i.e., spraying) and/or aspiration. For example, pressing theswitch can trigger the control 32 to allow pressure from the pump 8 andvalves 10 to be directed to the irrigation channel 24 (i.e., dischargetube) and consequently the atomization port 46 (e.g., spray nozzle), forexample via the exhaust (i.e., high pressure) side of the pump 8.

The device 2 can have a first switch configured to control, for examplevia the pump 8 and valves 10, pressure in the aspiration channel 26. Thedevice 2 can have a second switch configured to manually actuate a pump8 to deliver pressure to an irrigation channel 24 and an atomizationchannel 20 (i.e., spray mechanism), for example schematically analogousto a squirt-gun mechanism. The first switch can be activated by a firstdigit 39 (e.g., the thumb 42). The second switch can be activated by asecond digit 39 (e.g., the index finger 40), for example schematicallyand/or ergonomically analogous to a squirt-gun trigger 45.

The control 32 and/or pump 8 can be manually (e.g., user-induced) orautomatically (e.g., electrically) actuated and/or powered and/orotherwise controlled. The control 32, including the switch, can besimple and intuitive to use.

The head 14 can have one or more irrigation ports 48. The irrigationports 48 can be configured to dispense or otherwise discharge anirrigation fluid. The irrigation port 48 can be adjacent or within anatomizing port 46. The atomizing port 46 can be configured to dispenseor otherwise discharge the irrigation fluid in an atomizedconfiguration, for example, by mixing the irrigation fluid (e.g., in aliquid state) with an atomizing gas. The atomization channel 20 can havean input at an atomization reservoir 50 or from an external source(e.g., an intake port open to the outside air).

The head 14 can have a terminal end configured to be placed adjacent to,or inserted into, a biological orifice or surface to be irrigated andaspirated. For example, the terminal end of the head 14 can beconfigured to fit into a nostril. The terminal end of the head 14 canhave a pointed conical, rounded conical, nippled, or wastedconfiguration or combinations thereof.

The body 4 can be configured to be ergonomically held in a single hand.The body 4 can have contours to fit the palm 52 and fingers 40 whengrasped. With a filled irrigant reservoir 54 and/or aspirant reservoir56 and in-body power source 6 (e.g., containing one or more electricalcells), the device 2 can weigh less than or equal to about 5.0 kg (11lbs.), more narrowly less than about 2.0 kg (4.4 lbs.), for exampleabout 0.45 kg (1.0 lbs.). The irrigant 54 and/or aspirant reservoirs 56can be translucent and/or transparent, for example to allow a user toidentify when to replace irrigant 57 and/or empty aspirant 58, and/or tocheck cleanliness and/or operation of the device 2.

The irrigant 54 and/or aspirant reservoirs 56 can be cleanable, forexample dishwasher safe (e.g., the ability to withstand about 15 minutesat least at about 50° C., or more narrowly at least about 75° C.,without substantially noticeable deformation, deterioration, or otherdamage, and lack of substantial deterioration or other substantialdamage from similarly extended exposure to water and typical dishwasherdetergents).

The head 14 can have a nozzle 59 at or near the end of the head 14. Thenozzle 59 can be the tip of the head 14. The nozzle 59 can have theirrigation 48 and/or aspiration ports 60.

The aspiration channel 26 (e.g., vacuum lumen) for suctioning canconnect via the aspiration port 60 (e.g., vacuum portal) of the nozzle59 on the main housing. The aspiration channel 26 can lead to theaspirant reservoir 56 (e.g., collection chamber) for aspirant (e.g.,mucous) collection.

The device 2 can have multiple, diverging aspiration channels 26, forexample, to limit clogging. The aspiration channels 26 can have minimalor no tight radius curvature (e.g., the aspiration channels 26 can besubstantially straight), for example to limit clogging. The aspirationchannels 26 can have removably attached filters.

The aspirant reservoir 56 can be in the body 4 and/or, neck 12, and/orhead 14. The aspirant reservoir 56 can be configured to receive aspirant58 through an aspiration channel 26 and/or one or more aspiration ports60. The aspirant reservoir 56 can be integral or fixedly or removablyattached to the remainder of the device 2. The aspirant reservoir 56 canbe a replaceable cartridge or ampoule. The aspirant reservoir 56 canhold aspirant 59. The aspirant 59 can include biological fluids andtissue and/or previous dispensed irrigant 57. The aspirant reservoir 56volume can be, for example, about 5 mL.

The body 4 can have a cavity or recessed area in the housing for aremovable irrigant reservoir 54. The body 4 can have an integral orattached irrigant reservoir 54.

The irrigant reservoir 54 can be in the body 4 and/or, neck 12, and/orhead 14. The irrigant reservoir 54 can be configured to hold anddispense irrigant 57 through an irrigation or irrigant channel 24 and/orone or more irrigation ports 48. The irrigant reservoir 54 volume canbe, for example, about 5 mL.

Flow from the irrigant reservoir 54 can pass through an irrigantreservoir valve 62 before entering the irrigant channel 24 and/orirrigation port 48. The irrigant reservoir valve 62 can be a check valve(i.e., substantially or completely preventing backflow into the irrigantreservoir 54). For example, the irrigant reservoir valve 62 can be aball valve, swing valve, clapper valve, umbrella valve, double checkvalve, duck bill valve, as shown, or combinations thereof.

The irrigant reservoir 54 can be integral or fixedly or removablyattached to the remainder of the device 2. The irrigant reservoir 54 canhold irrigant 57. The irrigant reservoir 54 can be a replaceablecartridge or ampoule. The irrigant reservoir 54 can be disposable,replaceable, recyclable, or combinations thereof. The irrigant reservoir54 can be pre-filled with irrigant 57 or ready for adding all or acomponent (e.g., water) of the irrigant 57. The irrigant reservoir 54can be divided into multiple sub-reservoirs. For example, onesub-reservoir can have salt and another irrigant reservoir 54 can havewater. The sub-reservoir contents can mix (e.g., creating salinesolution) when the irrigant is dispensed.

The irrigant reservoir 54 can be the same volume, a larger volume than,or a smaller volume than the aspirant reservoir 56. For example, theaspirant reservoir 56 volume can be about 100 or less times larger thanthe irrigant reservoir 54 volume, or more narrowly, about 20 or lesstimes larger than the irrigant reservoir 54 volume, or more narrowly,about 7 or less times larger than the irrigant reservoir 54 volume, ormore narrowly, about 3 or less times larger than the irrigant reservoir54 volume, or more narrowly about 1.5 or less times larger than theirrigant reservoir 54 volume, for example the aspirant reservoir 56volume can be about 1.25 times the irrigant reservoir 54 volume.

The irrigant reservoir 54 can be a first color (e.g., blue), theaspirant reservoir 56 can be the first color or a second color (e.g.,yellow or red). The irrigant reservoir 54 and/or aspirant reservoir 56can be transparent, translucent or opaque. The irrigant reservoir 54 canseat into the device 2 in a different configuration than the aspirantreservoir 56. For example, the irrigant reservoir 54, aspirant reservoir56 and the remainder of the device 2 can be configured so as to not beable to insert the irrigant reservoir 54 in the device 2 in place of theaspirant reservoir 56 and/or vice versa.

The irrigation fluid or irrigant 57 can have or be water, salinesolution, zinc solution (e.g., zinc sulfate solution), alcohol,anesthetic agent, analgesic agent, antipyretic agent, anti-inflammatoryagent such as a non-steroidal anti-inflammatory agent (e.g., ibuprofen,aspirin, salicylic acid, COX02 inhibitor, COX-3 inhibitor),acetaminophen, live attenuated flu vaccine, antihistamine (e.g.,azelastin hydrocholoride), corticosteroid (e.g., fluticasonepropionate), topical decongestant (oxymetazoline hydrochloride), vitamin(e.g. vitamin c, ascorbic acid), nicotine, other therapeutic ordiagnostic medication, or combinations thereof.

The irrigant 57 can combine with an atomizing gas at the atomizing port46. The atomizing port 46 can be a nozzle 59 configured to atomize theirrigant 57.

The atomizing gas can have or be air, carbon dioxide, oxygen, nitrogen,nitrous oxide, another anesthetic, or combinations thereof.

FIG. 3 illustrates a variation of the head 14 with irrigant 57 andaspirant 58 flow. Irrigant pressure 64, as shown by arrow, can beapplied to the irrigant reservoir 54. The irrigant pressure 64 can forcethe irrigant 57 from the irrigant reservoir 54 through the irrigationchannel 24.

Atomizing pressure 66, as shown by arrows, can be applied to theatomizing channel 20. The atomizing pressure 60 can for the atomizinggas through the atomizing channel 20.

The nozzle 59 can be configured to mix the irrigant 57 and the atomizinggas at the atomizing port 46. The nozzle 59 can be configured tonebulize or atomize the irrigant 57 with the atomizing gas as theirrigant 57 flows out of the atomizing port 46. The atomized irrigant 68can flow away from the nozzle 59.

The atomized irrigant 68 can include particles having a diameter fromabout 0.1 μm (0.004 mil) to about 100 μm (4 mil) upon exit from theatomization port 46. The atomized irrigant 68 particles can have a highmobility and can substantially uniformly coat, adhere and interact withthe target site, tissues, and fluids.

The irrigant 57 can be delivered as one or more anatomized streams(i.e., shower-like) without the mixing with an atomizing gas. Forexample, the device can have no atomization channel 20.

The nozzle 59 can be configured to deliver the irrigant 57 in a streamor flood (e.g., not atomized), for example by having no atomization port46 (e.g., or other atomization elements).

A negative aspirant pressure 67 can be applied to the aspirant reservoir56. The aspirant 58 can flow, as shown by arrows, through the aspirationports 60 and into the aspirant reservoir 56. The aspirant 58 can collectin the aspiration reservoir 56.

The irrigant port 48 and atomizing port 46 can be radially central tothe terminal end of the head 14. The aspirant ports 60 can be radiallyoff-center or otherwise away from the irrigant port 48 and atomizingport 46 on the head 14.

There is an inner lumen (irrigation lumen) of the nozzle 59 that iseither central or eccentric which delivers a spray of saline uponmanual/automatic actuation, much like a water gun inside of a suctiondevice. This portion of the nozzle 59 corresponds to the aspirationportal 60 of the nozzle 59 base on the main housing.

The control 32, pumps 8, and heads 14 can be configured to providevarious irrigation flow characteristics. For example, the device 2 canbe configured to flood (e.g., unbroken, unhollow stream, for examplesubstantially cylindrical stream), and/or atomize, and/or conical (e.g.,hollow or unhollow conical stream) irrigation characteristics. The flowcharacteristics can be automatically or manually adjusted. The nozzle 59or head 14 can be manually replaced with a differently configured nozzle59 or head 14 to change the irrigation characteristics.

FIGS. 4 and 5 illustrate that the aspiration port 60 can have an inflowcheck (i.e., one-way) valve 10 for inflow configured to substantially orcompletely prevent backflow of aspirant 58 from the aspiration channel26 or reservoir 56. The inflow check valve 10 can be or have a ballvalve, swing valve, clapper valve, umbrella valve, double check valve,duck bill valve 70, as shown, or combinations thereof. The inflow checkvalve 10 can be integral or fixedly or removably attached to theaspiration port 60 and/or the aspiration channel 26 and/or the aspirantreservoir 56. The aspiration port 60 can be radially central to theterminal end of the head 14. The irrigation channel 24 can be radiallyoff-center or otherwise away from the aspirant port 60 on the head 14.

The head 14 can have an attachment ring 72 on the inside or outside ofthe head 14. The attachment ring 72 can be configured to attach to theneck 12 and/or the body 4.

FIG. 6 illustrates that the aspiration channel 26 or aspirant reservoir56 can have a exhaust trap 74. The exhaust trap 74 can have a trap valve76. The trap valve 76 can be a resilient flap. The trap valve 76 can bea check valve 10 configured to release excessive pressure from theaspirant reservoir 56 and/or aspirant channel 26 into the exhaust trap74. For example, the excessive pressure in the aspirant reservoir 56 oraspiration channel 26 can force fluid (i.e., aspirant 58 or gas in theaspirant reservoir 56 or aspiration channel 26) between the trap valve76 and a relatively rigid trap flange 78. The contact area of the trapvalve 76 and the trap flange 78 can be a trap intake seal 80.

The trap flange 78, and/or aspiration channel 26 can direct incomingflow of aspirant 58 from the aspiration port 60 adjacent to the trapintake seal 80 so that a low pressure is naturally produced on theaspiration channel-side 26 and/or aspirant reservoir-side 56 of the trapintake seal 80 during, aspirant 58 flow from the aspiration port 60 intothe aspirant reservoir 56.

The exhaust trap 74 can drain through an exhaust trap port 82 to theoutside of the device 2 or to a separate overflow exhaust reservoir (notshown). The exhaust trap port 82 can be open or can have a manual orautomatic pressure release valve 10, for example a check valve 10. Thedevice 2 can be configured to drain aspirant 58 (e.g., passively orunder applied pressure) from the aspirant reservoir 56 through theexhaust trap 74 and the exhaust trap port 82.

The exhaust trap 74 can have a trap overflow seal 84. The trap overflowseal 84 can be a check valve 10 configured to release excessive pressurefrom the exhaust trap 74 into the aspiration channel 26 and/or aspirantreservoir 56. The trap overflow seal 84 can be made from a portion ofthe trap valve 76 and the outer wall of the aspiration channel 26 oraspirant reservoir 56.

The aspiration valve 86 can be integral with or attached to anaspiration valve gasket 88. The aspiration valve 86 and/or aspirationvalve gasket 88 can be snap-fit (as shown, around an extending ring orcollar configuration), press-fit, attached with an adhesive, orotherwise attached to the aspiration port 60.

The irrigation channel 24 can be located in the irrigant reservoir 54.

FIGS. 7 and 8 illustrate that the irrigation channel 24 can beconcentric with the atomizing channel 20. The irrigation channel 24 canbe in an irrigation conduit 90. The atomizing channel 20 can be in anatomizing conduit 92. The irrigation conduit 90 can be concentric withthe atomizing conduit 92. The irrigation channel 24 can be inside theatomizing conduit 92.

The aspiration valve 86 can be a check valve 10 concentric with theatomizing port 46 and/or irrigation port 48. The aspiration valve 86 canform the aspiration seal 94 against the aspiration 96 and/or irrigationconduit 90.

FIG. 9 illustrates that the irrigation conduit 90 can have first 98,second 100, third 102 and more atomizing vanes. The vanes can beconfigured to radially extend from the center of the irrigation conduit90. The vanes can longitudinally extend along all or part of theirrigation conduit 90. The vanes and the atomizing conduit 92 can formfirst 104, second 106, third and more atomizing sub-channels within theatomizing channel 20. The atomizing sub-channels can be venturis 185.The edges of the vanes can be sharpened, for example to induce turbulentflow around the edges of the vanes.

The concentric tube design (i.e., with the irrigation channel 24internal to a concentric aspiration channel 26 (proximal to therespective ports) can have the outer tube (e.g., atomization channel 20)be shorter than the inner tube (e.g., irrigation channel 24). Thedifference in length between the atomization 20 and irrigation channels24 can allow for the irrigant 57 to be atomized when pressurizedirrigant 57 passes up the center tube (e.g., irrigation channel 24)which can be filled from the reservoir, and pressurized air can passthrough the outer tube (e.g., aspiration channel 26).

The concentric tube design can be inverted with respect to theconfiguration described supra. For example, the irrigant reservoir 54can be inverted and the atomization channel 20 can be central to theconcentric irrigation channel 24. The nozzle 59 can be “flooded” tospray the irrigant 57 by filling the outer tube (i.e., irrigant channel24) with pressurized irrigant 57 and the inner tube (e.g., atomizationchannel 20) with pressurized air or other gas. For example, infants canbe laying down and receive drops of irrigant 57 and toddlers can besitting up and receive atomized irrigant 57.

FIGS. 10 and 11 illustrate that the irrigation conduit 90 can beintegral with or attached to the head 14. The head 14 can have anirrigation conduit port 108. The irrigation conduit port 108 can receivethe irrigation conduit 90.

FIGS. 10 through 13 illustrate that the head 14 can have first 110,second 112 and more atomizing channels 20. The atomizing channels 20 canbe on the outer surface of the head 14. The atomizing channels 20 canhave venturis 185.

The irrigation channel 24 in the head 14 can extend from the irrigationconduit port 108 to the irrigation port 48 (not shown, but can belocated inside the head 14 and adjacent to or in the atomizing port 46).The first and second aspiration channels 26 can merge. The first andsecond aspiration channels 26 can merge adjacent to the irrigation port48. The first and second aspiration channels 26 can merge adjacent tothe aspiration port 60.

The atomization gas can flow from outside the head 14, for example fromoutside the device 2 or from an atomization conduit 92 within, attached,or adjacent to the irrigation conduit 90.

FIG. 14 illustrates that the irrigation port 48 can be located adjacentto the aspiration port 60. The irrigation port 48 can be completely orpartially surrounded by the aspiration port 60. The aspiration port 60can be completely or partially surrounded by the irrigation port 48. Theirrigation conduit 90 can be inside the aspiration conduit 96. Theirrigation conduit 90 can be non-concentric with the aspiration conduit96. The irrigation port 48 can be flush on one side of the aspirationconduit 96.

FIG. 15 illustrates that the head 14 can have one or more ports(representing the irrigation 48 and/or aspiration 60 and/or atomizationports 46). The head 14 can be configured as a bulb 114. Non-skewedalignment along a longitudinal axis of the head 14 presents a secondarychallenge to the user and/or patient. FIG. 1 illustrates that theterminal end of the head 14 can be configured as a nipple 116. Theterminal end of the head 14 can be bulged or waisted. The terminal endof the head 14 can have a larger radius distal to the port 118, forexample, to prevent overinsertion of the head 14 into a natural bodyorifice.

The terminal end of the head 14 can be configured to make a positiveseal with the irrigation and aspiration site (e.g., the nostril). Thehead 14 can seal to the irrigation and aspiration site analogous to aball and socket joint and/or similar to nested tubes. The terminal endof the head 14 can be rotationally symmetric about a longitudinal axisof the head 14. The rotational alignment can be decoupled from thesealing functionality, for example allowing one more degree of freedomfor the user.

The terminal end of the head 14, or all of the head 14, can be made fromand/or covered or coated with, a compliant material such as siliconerubber or foam. The terminal end of the head 14 or all of the head 14can be compliant, for example, to permit sealing to differently-shapednostrils. The terminal end of the head 14, or all of the head 14 can besufficiently rigid to not deform against the negative pressure of theaspiration.

The head 14 can have an irrigation component 120 and an aspirationcomponent 122. FIG. 17 illustrates that the irrigation component 120 canhave a piston 124 within a cylinder. The piston 124 can have one or moregaskets 126. The gaskets 126 can fluidly seal between the piston 124 andthe cylinder. The piston 124 can have a nozzle 59 at a terminal end ofthe piston 124. The piston 124 can be integral with or attached to theatomizing channel 20 and the irrigant channel 24.

The irrigation component 120 can have a resilient valve 10 or seal, forexample an elastomeric seal 127. The elastomeric seal 127 can fluidlyseparate the nozzle 59 from the outside of the head 14 (e.g., duringuse, the nasal cavity, for example), for example when the device 2 is ina retracted (e.g., not irrigating) configuration.

The cylinder can be volumetrically rigid or compliant (e.g., if desiredto expand to accommodate excessive pressures). The cylinder can have acylinder top 128 and a cylinder bottom 130. The cylinder top 128 can bethe volume fluid sealed by the piston 124 from the volume of thecylinder bottom 130. The atomizing channel 20 can have one or morecylinder ports 132 into the cylinder top 128 and/or cylinder bottom 130.The cylinder port 132 can have an active or passive valve 10.

FIG. 18 illustrates that high pressure fluid (e.g., atomizing gas) canbe introduced under an atomizing pressure 66, as shown by arrows, intothe atomizing channel 20. The atomizing pressure 66 can enter thecylinder bottom 130 or top 128 (for exemplary purposes, shown ascylinder bottom 130). Force from the atomizing pressure 66 and/oranother force (e.g., from a motor not shown) can translate, as shown byarrows 300, the piston 124 toward the elastomeric seal 127.

The nozzle 59 can be translated toward and out the elastomeric seal 127.The translation of the nozzle 59 can cause the seal 126 to rotate open,as shown by arrows 302. The rotated open elastomeric seal 127 canfluidly seal against the nozzle 59, for example directly or via one ormore gaskets 126.

The atomization port 46 can translate out of the elastomeric seal 127,as shown by arrow 304. The irrigant 57 can be delivered via theirrigation port 48, for example with the flow exiting the atomizing port46 unobstructed by the elastomeric seal 127.

Instead of, or in combination with, a piston-deployed irrigationcomponent 120, the device 2 can have a reciprocating and/orsyringe-deployed irrigation component 120, similar to thepiston-deployed irrigation component 120 shown in FIGS. 17 and 18.

FIG. 19 illustrates that the head 14 can have a single combined port 135for aspiration and irrigation. The aspiration can occur concurrently orsubsequent to the irrigation. The aspiration channel 26 can beconfigured to direct the suction pressure of the aspiration adjacent tothe perimeter of the combined port 135. The irrigation channel 24 can beconfigured to direct the irrigation to the center of the combined port135.

The irrigation channel 24 can have an irrigation channel lining 134. Theirrigation channel lining 134 can actively (e.g., can be movable, suchas an electro-active polymer skin) or passively (e.g., by the shape ofthe channel lining 134) focus the exiting stream of irrigant 57. Theirrigation channel lining 134 can form a venturi 185 in the irrigationchannel 24. The irrigation channel lining 134 can be integral with, orfixedly or removably attached to the irrigation channel 24.

The irrigation channel 24 can have an irrigation channel break 136. Theirrigation channel break 136 can be configured to act as a venturi 185.The irrigation channel break 136 can be configured to increaseturbulence in the flow of the irrigant 57 through the irrigation channel24.

FIG. 20 illustrates that the irrigation component 120 can have anatomizing reservoir 50 or atomizing channel 20 (labeled as a reservoirfor exemplary purposes) partially or completely circumferentiallysurrounding the irrigant reservoir 54 or irrigant channel 24. Theatomizing reservoir 50 can be embedded in the wall of the irrigationcomponent 120, for example in the wall or case of the irrigant reservoir54. The irrigation component 120 can be resiliently flexible. Theaspirant 58 and irrigant 57 can be delivered by squeezing the irrigationcomponent 120.

The irrigation conduit 90 can be molded into the wall of the irrigationcomponent 120.

The irrigation channel 24 can form a venture 185. The irrigation channel24 can have an irrigation channel diameter 138. The irrigation channeldiameter 138 can be the minimum internal diameter of the irrigationchannel 24. The irrigation channel diameter 138 can be less than about 1cm (0.4 in.), more narrowly less than about 2 mm (0.8 in.), for exampleabout 0.7 mm (0.03 in.).

FIG. 21 illustrates that the aspiration reservoir 56 can be a resilientcontainer, such as an elastomeric bulb 114. The aspiration reservoir 56can have an exhaust conduit 140. The exhaust conduit 140 can be in fluidcommunication with the aspiration reservoir 56. The exhaust conduit 140can have an exhaust valve 142 and an exhaust port 144. The exhaust valve142 can be an check valve 10 configured to flow away from the aspirationreservoir 56.

The nozzle 59 can be integral with or removably attached to theaspiration reservoir 56. The aspiration port 60 nozzle 59 or theaspiration reservoir 56 can have an aspiration valve 146. The aspirationvalve 146 can be a check valve 10, for example any check valve 10 statedherein such as an umbrella check valve 147.

The irrigation component 120 can have an irrigation trigger 148. Theirrigation trigger 148 can be operated by a single digit 39. When theirrigation trigger 148 is pulled, the irrigation component 120 candispense irrigant 57.

When the aspiration reservoir 56 is squeezed, the aspiration valve 86can close and the exhaust valve 142 can open. The aspirant 58 in theaspiration reservoir 56 can be forced out the exhaust conduit 140 andthe exhaust port 144. The exhaust valve 142 can be a duckbill valve 70.When the previously-squeezed aspiration reservoir 56 is relaxed, theexhaust valve 142 can close and the aspiration valve 86 can open.Suction can then result at the aspiration port 60 and aspirant 58 can bedrawn into the aspiration reservoir 56.

FIG. 22 illustrates that the aspiration valve 86 can be a duckbill valve70 (the irrigation component 120 is not shown). The aspiration component122 and/or the device can have a base 150. The base 150 can beconfigured to enable the device 2 to stand on a flat surface (e.g., atable), for example, keeping the aspiration 60 and atomization 46 and/orirrigation ports 48 off the flat surface.

FIGS. 23 and 24 illustrate that the irrigation port 48 can be centrallylocated within a substantially circular aspiration port 60. Theaspiration port 60 and the irrigation port 48 can be at the outersurface of the head 14 and/or the aspiration port 60 and/or theirrigation port 48 can be recessed within the head 14.

The head 14 can have the aspiration reservoir 56 and the irrigationreservoir 54. The aspiration reservoir 56 can be in direct fluidcommunication with the aspiration port 60.

The device 2 can have one or more valves 10 configured to control theirrigation delivery pressure and/or the aspiration suction pressure. Thevalves 10 can be actuated by one or more buttons 34, such as apress-button 34, as shown. The valves 10 can be in fluid communicationwith the pump 8 and the irrigant pressure line 22, aspirant pressureline 18 and atomizing channel 20, and an exhaust port 144 and intakeport 152. In closed positions, the valves 10 can bleed or releasepressure to the exhaust port 144 and/or suction through the intake port152. In opened positions, the valves 10 can delivery positive pressurefrom the pump 8 to the irrigant pressure line 22 and the atomizingchannel 20, and negative pressure from the pump 8 to the aspirantpressure line 18.

The pump can be a piston 124 and/or diaphragm pump 8, such as the dualdiaphragm pump 8, as shown in FIGS. 23 and 24.

The aspirant reservoir 56 and/or irrigant reservoir 54 can be in thehead 14. The aspirant reservoir 56 and/or irrigant reservoir 54 can bein direct fluid communication (e.g., not via a separate channel) withthe aspiration port 60 and/or irrigation port 48, respectively. The lackof a separate channel connecting the aspirant 56 and/or irrigationreservoir 54 and the aspiration port 60 and/or irrigation port 48,respectively, can obviate the need to clean the separate channel.

The device 2 can have a portable power source 6, such as batteries, asshown in FIGS. 23 and 24. For example, the device 2 can have 1, 2, 3 or4 AA-sized cells. The cells can be inserted through a battery door 30 inthe bottom of the device.

The pump 8 can be connected to a control 32 or controller, such as amotor. The control 32 can have a microprocessor configured to regulatethe motor speed to control irrigant delivery pressure and/or aspirantsuction pressure. The aspirant suction pressure can be, for example,from about 80 mm Hg (1.5 psi) to about 120 mm Hg (2.32 psi). The control32 can receive an input from the button 34. The microprocessor cananalyze the button position to control the motor speed and/or valve 10position.

FIGS. 25 and 26 illustrate that the grip pads 28 can be ergonomicallyplaced on the front and back of the body 4. The grip pads 28 can haveridges or texturing. The grip pads 28 can be made from metal, softplastic or rubber. The head 14 can be opaque, transparent and/ortranslucent. The head 14 can be removably attached to the neck 12 and/orthe neck 12 can be removably attached to the remainder of the body 4.

FIG. 27 illustrates that the irrigant 57 can be refilled. The irrigantreservoir 54 can have an irrigant reservoir seal 154 against the outerwall of the irrigant reservoir 54. For example, the irrigant reservoirseal 154 can be plastic. The irrigant reservoir seal 154 can be selfsealing and/or manually controlled to open and close.

An external irrigant container 156 can have fresh irrigant 57. Theexternal irrigant container 156 can have a container spout 158configured to insert into the irrigant reservoir 54 through the irrigantreservoir seal 154. The external irrigant container 156 can be advancedinto the irrigant reservoir seal 154, as shown by arrow. The contents ofthe external irrigant container 156 can then be deposited into theirrigant reservoir 54, for example by squeezing the external irrigantcontainer 156 and/or by opening a pressure release port (not shown) onthe external irrigant container 156. The irrigant 57 in the externalirrigant container 156 can then be transferred into the irrigantreservoir 54. The external irrigant container 156 can then be removedfrom the irrigant reservoir seal 154 and the irrigant reservoir seal 154can close.

FIG. 28 illustrates that the head can have a cartridge receptacle 160configured to removably attach to an irrigant cartridge 162. Thecartridge receptacle 160 can have ports, hooks, latches, pegs, orcombinations thereof that can removably attach to the same on theirrigant cartridge 162. When the irrigant cartridge 162 is not attached,the cartridge receptacle 160 can define a void substantially equivalentto the configuration of the irrigant cartridge 162.

The irrigant cartridge 162 can have the irrigant reservoir 54 that cancontain irrigant 57. The irrigant cartridge 162 can be inserted into theirrigant receptacle 160, as shown by arrow. The irrigant cartridge 162can have one or more ports (not shown) that can engage the irrigantpressure line 22 and/or irrigant channel 24 when the irrigant cartridge162 is attached to the cartridge receptacle 160. The ports 118 on theirrigant cartridge 162 can be closed or covered, for example by adheredaluminum foil when the irrigant cartridge 162 is not in the cartridgereceptacle 160. For example, the cartridge receptacle 160 can have oneor more fangs or tubes configured to pierce the irrigant cartridge 162(e.g., through a foil or seal) and be in fluid communication with theinterior of the irrigant cartridge 162 and pressurize or depressurizethe irrigant cartridge 162 and/or withdraw irrigant from the irrigantcartridge 162.

A first irrigant cartridge 162 can be removed from the irrigantreceptacle 160 and replaced with a second irrigant cartridge 162, forexample when the first irrigant cartridge 162 is empty.

In another variation, when the irrigant reservoir 54 is empty and/or theaspirant reservoir 56 is full or otherwise in need of emptying orcleaning, the entire head 14 can be removed from the neck 12 andreplaced with a second head 14 containing more irrigant 57 in theirrigant reservoir 54. Likewise, the aspirant reservoir 56 can beremoved (similar to the sole removal of the irrigant cartridge 162). Thehead 14 and/or irrigant reservoir 54 and/or aspirant reservoir 56 and/orthe device 2 can be washed, for example, by hand and/or in a dishwasher.The body 4 and/or the device 2 can be waterproof.

FIG. 29 illustrates that the aspiration reservoir 56 can be in aresilient vacuum bulb 164. The vacuum bulb 164 can be elastomeric. Theaspiration reservoir 56 can be in fluid communication with theirrigation reservoir 54, for example, via an irrigation-aspiration port166. The irrigation-aspiration port 166 is configured to be away fromthe aspirant fluid level in the aspirant reservoir 56.

An irrigation-aspiration valve 168 can be in fluid communication withthe aspiration reservoir 56 and the irrigation reservoir 54. Theirrigation-aspiration valve 168 can be a check valve 10. Theirrigation-aspiration valve 168 can be a valve 10 permitting flow onlyfrom the aspiration reservoir 56 to the irrigation reservoir 54 andpreventing flow from the irrigation reservoir 54 to the aspirationreservoir 56.

The aspiration valve 146 can be a one-way check valve 10 permitting flowinto the aspiration reservoir 56.

The irrigation reservoir 54 can be in an irrigation container 170. Theirrigation container 170 can be rigid, for example a plastic bottle. Theirrigation container 170 can be integral with or removably attachable tothe remainder of the device at an attachable reservoir joint 172. Theatomization fluid reservoir 174 can be the top of the irrigationreservoir 54, above the level of the irrigant 57.

The base 150 can extend from the reservoir container. The base 150 canbe wider than the widest portion of the remainder of the device 2.

Squeezing the vacuum bulb 164 can atomize and eject irrigant 57 from theatomization port 46. For example, when the vacuum bulb 164 is squeezed,the irrigation-aspiration valve 163 can open and the irrigationreservoir 54 can be pressurized via the irrigation-aspiration port 166.The increased pressure in the irrigation reservoir 54 can cause theirrigant 57 to flow through the irrigation channel 24. The increasedpressure in the irrigation reservoir 54 can also force gas in theirrigation reservoir 54 (e.g., above the irrigant 57) through theatomization channel 20.

Relaxing the previously squeezed irrigation-aspiration valve 168 cansuction aspirant 58 into the aspiration reservoir 56. For example, theirrigation-aspiration valve 168 can close. The negative pressure in theaspiration reservoir 56 can draw in aspirant 58 by opening theaspiration seal 94 in the aspiration port 60.

FIG. 30 illustrates that one or more covers 175 can be configured to fitover the aspiration 60 and/or irrigation 48 and/or atomization ports 46.

The device 2 can have a manually or automatically controllable dualexhaust valve 176. The dual exhaust valve 176 can be passive or active.The dual exhaust valve 176 can regulate excessive fluid pressure fromthe aspiration reservoir 56 and/or the irrigant reservoir 54 to anexhaust conduit 140. The excessive fluid pressure can exit the exhaustconduit 140 as an exhaust flow, shown by arrow.

An irrigation valve 178 can regulate flow from the irrigant reservoir 54to the irrigation port 48. The irrigation valve 178 can be configured toprevent the irrigant 57 from exiting the irrigation port 48 at anexcessive pressure. The velocity of the irrigant 57 flow stream can beprevented from exiting the device 2 at an excessive velocity.

FIGS. 31 and 32 illustrate that the aspirant reservoir 56 can be in aninner irrigant reservoir wall 180. The irrigant reservoir 54 can bebetween an inner irrigant reservoir wall 180 and an outer irrigantreservoir wall 182. The inner irrigant reservoir wall 180 and the outerirrigant reservoir wall 182 can be rigid, resilient or deformable.

The device 2 can have an atomization intake port 184 on the outsidesurface of the device 2. The atomization intake port 184 can be in fluidcommunication with the atomization fluid reservoir 174. The atomizationintake port 184 can have a check valve 10 configured to allow one-wayflow from the atomization intake port 184 to the atomization fluidreservoir 174.

The atomization valve 186 can regulate flow between the irrigantreservoir 54 to the atomization channel 20. The atomization channel 20can have a venturi 185 configuration adjacent to the irrigation port 48.The venturi 185 can atomize the irrigant 57 and/or increase the speed ofthe atomization gas.

The irrigant valve 178 can regulate flow between the irrigant reservoir54 and the irrigant channel 24. The irrigant valve 178 can be a checkvalve 10. The irrigant valve 178 can prevent flow from the irrigantchannel 24 to the irrigant reservoir 54. The irrigant valve 178 canpermit substantially free flow from the irrigant reservoir 54 to theirrigant channel 24. The irrigant valve 178 can restrict the flow fromthe irrigant reservoir 54 to the irrigant channel 24 except under highpressure differentials, for example a pressure differential greater thanabout 25 mmHg (0.5 psi), more narrowly a pressure differential greaterthan about 100 mmHg (2 psi), more narrowly a pressure differentialgreater than about 260 mmHg (5 psi), more narrowly a pressuredifferential greater than about a pressure differential greater thanabout 760 mmHg (14.7 psi), for example for a pressure differentialgreater than about 1600 mmHg (30 psi).

An irrigant intake port 188 can be in fluid communication with theirrigant reservoir 54. The irrigant intake port 188 can have a checkvalve 10 configured to allow one-way flow from the irrigant intake port188 to the irrigant reservoir 54. The irrigant reservoir 54 can befilled by introducing irrigant 57 through the irrigant intake port 188.

The aspiration channel 26 can have a valve transition zone 190. Thevalve transition zone 190 can be configured as a smooth transition fromthe inner wall of the aspiration channel 26 to the inner wall of theaspirant valve 146.

An exhaust valve 142 can regulate flow between the aspirant reservoir 56and the exhaust port 144. The exhaust port 144 can be covered anduncovered by the user (e.g., by a digit 39, such as the thumb 42) duringuse. The exhaust can flow from the aspirant reservoir 56 and out theexhaust port 144, as shown by arrow.

The device 2 shown in FIGS. 31 and 32 can be squeezed to deliver theirrigant Releasing the device 2 from a squeezed configuration canaspirate.

FIG. 32 shows that the irrigant 57 and atomization fluid can be mixed amixing valve 192. The mixing valve 192 can be upstream from theatomization port 46.

FIG. 33 illustrates that the device 2 can have a body 4 that can beattached to the head 14 with a lead 194. The lead 194 can carry theirrigant pressure line 22 and/or irrigant channel 24, aspirant pressureline 18 and/or aspirant channel 26, atomization channel 20 orcombinations thereof. The lead 194 can be flexible. The lead 194 can beretractable into the body 4, for example with a spring-loaded retractionmechanism. The lead 194 can be coiled. The head 14 can have a removablyattached aspirant reservoir 56 and/or irrigant reservoir 54 (not shownseparately).

The body 4 can have a flat base 150. The body 4 can be attached to asurface such as a flat surface (e.g., floor, table, crib), for examplewith screws, nails, brads, bolts or combinations thereof. The body 4 canbe weighted with ballast and/or have a clamp (e.g., to stabilize).

FIGS. 34a through 34c illustrate that the fluid control 32 and pump 8can have a motor 306 attached to a first 196 (and/or second diaphragm198). The pump 8 can be a piston 124 or diaphragm pump 8 (i.e., amembrane pump, positive displacement pump). The pump 8 can be a boxerpump 8, having at least two oppositely-oriented oscillating shafts,rods, or membranes. The pump 8 can be or have a compressed gas (e.g.,air, carbon dioxide, nitrogen) canister that can be configured tocontrollably release the compressed gas.

The pump 8 can be similar in geometry to a Daco pump 8. The pump 8 canhave doubled-up diaphragms. The pump 8 can be driven by a motor 306 thatcan be driven by the power source 6. The device 2 can produce a maximumirrigant volumetric flow rate of at least about 9,000 cc/m, morenarrowly at least about 12,000 cc/m, yet more narrowly at least about15,000 cc/m.

The pump 8 can have one or more blowers, turbines, fans, diaphragms,bellows, or combinations thereof. The pump 8 can be manually and/orelectrically powered. The pump 8 can be attached to an AC or DC-drivenmotor.

FIG. 35 illustrates that a user can ergonomically hold the body 4 in asingle hand. The user can rest a digit 39, such as the thumb 42, on thebutton 34. The palm 52 and/or other fingers 40 can substantially orcompletely rest on the grip pads 28.

FIG. 36 illustrates that the thumb 42 can slidably translate the button34, as shown by arrow. The slidable translation 36 of the button 34 cancontrol irrigation or aspiration. As shown for example, sliding thebutton 34 can actuate the device 2 to create a suction resulting inaspirant flow 200, as shown by arrow. The distance the button 34 isslidably translated 36 can directly correlate to the pressure of theaspiration or irrigation.

FIG. 37 illustrates that the thumb 42 can slidably translate 36, asshown by arrow, and concurrently depressingly translate 38, as shown byarrow, the button 34. The depressing translation 38 can control theother of the irrigation or aspiration not controlled by the slidingtranslation 36. Sliding and depressing, the button 34 can actuate thedevice 2 to create a suction resulting in aspirant flow 200, as shown byarrow, and resulting in a pressured fluid delivery resulting in theirrigant flow 202, as shown by arrow.

FIG. 38 illustrates that the device 2, such as the variation shown inFIG. 21, can be actuated to irrigate by rotating 308 a trigger 45 on ahinge, for example with one or more digits 39 (e.g., the forefingerand/or middle finger). The aspirant reservoir 56 can be completely orpartially emptied by compressing 41, as shown by arrows, the aspirantreservoir 56, for example with the thumb 42, ring finger, pinky and palm52. The aspirant 58 can be drawn into the aspiration port 60 byreleasing the compressed aspirant reservoir 56.

Variations of the device 2, such as those shown in FIGS. 29 through 32,can be actuated by squeezing (e.g., for irrigation) and releasing (e.g.,for aspiration) all or part of a resilient portion of the device 2, suchas a bulb 114.

FIG. 39 illustrates that the pump 8 can draw air from the aspirantreservoir 56. The resulting vacuum can draw aspirant flow 200, as shownby arrows, through the aspiration ports 60. The irrigant pressure line22 can have an excess flow port 204. The excess flow port 204 can bleedexcess pressure out of the irrigant pressure line 22 as exhaust flow206.

The device 2 can have a first valve 208 in a controlled exhaust line 210in fluid communication with the irrigant pressure line 22. The firstvalve 208 can be actuated by a button 34. The button 34 can be in aposition configured to produce aspiration and no irrigation. All or partof the exhaust pressure from the pump 8 can flow out of the device 2 asexhaust flow 206, as shown by arrows. All or part of the exhaustpressure from the pump 8 can flow throw the atomization channel 20 andout the atomization port 46. The flow through the atomization port 46,as shown by arrows, can, for example, prevent aspirant from passivelyflowing into the atomization port 46. The irrigation pressure line 22can be significantly smaller than the controlled exhaust line 210. Forexample, no or unsubstantial flow can be generated in the irrigantpressure line 22 while the controlled exhaust line 210 is open.

FIG. 40 illustrates that the button 34 can be translated 220, as shownby arrow, to a configuration to produce aspiration and irrigation. Thebutton 34 can directly (as shown) or indirectly (e.g., via a controlmechanism such as a valve 10 attached to a servomotor) close thecontrolled exhaust line 210. The flow can be the same as shown in FIG.31 except that substantial positive pressure can be routed through theirrigant pressure line 22. The irrigant 57 can be forced through theirrigant channel 24, into the atomization port 46, mixed with theatomization gas, and sprayed out as atomized irrigant 68. Excessivepressure in the irrigant pressure line 22 can be released as exhaustflow 206, as shown by arrow.

The device 2 can be configured to prevent the irrigant 57 from theirrigant reservoir 54 from flowing solely from the application ofpressure in the aspirant pressure line 18 or aspirant channel 26. Forexample, the irrigant reservoir 54 can be locked closed (e.g.,preventing any irrigant 57 from exiting the irrigant reservoir 54) by alocking valve (e.g., piston 124 or syringe) when the device 2 isconfigured to not irrigate (e.g., the irrigation control 32 is set to“off”). When the device 2 is configured to not irrigate, excess pressurefrom the aspirant pressure line 18 and/or aspirant channel and/or thenegative pressure side of the pump 8 can be exhausted out of the device2.

FIG. 41 illustrates that the device 2 can have a first valve 208 and/ora second valve 224. The first valve 208 can be between the pump 8 andthe atomization channel 20 and/or irrigant pressure line 22 and anexhaust port 144. The second valve 224 can be between the pump 8 and theaspirant pressure line 18 and an intake port 152. Intake flow 310 canflow into intake port 152. The first 208 and second valves 224 can be inthe same housing or separate housings. The valves can act as switchesfor routing the air pressure to and from the pump 8. The button 34 andvalve spring 226 can control the position of the valve channel 228.

FIG. 42 illustrates that the first valve 208 can be in a firstconfiguration to direct the flow from the pump 8 to the exhaust port 144and to obstruct flow from the pump 8 to the atomization channel 20and/or irrigant pressure line 22. The button 34 can be up and the valvespring 226 can be expanded. Flow from the pump 8 to the exhaust port 144can flow through the valve channel 228. Flow from the pump 8 to theatomization channel 20 and/or irrigant pressure line 22 can be blockedby the first valve 208. The irrigant delivery pressure can be shut offcompletely or partially.

FIG. 43 illustrates that the first valve 208 can be in a secondconfiguration to direct the flow from the pump 8 to the atomizationchannel 20 and to obstruct flow from the pump 8 to the exhaust port 144.The button 34 can be down and the valve spring 226 can be compressed.Flow from the pump 8 to the atomization channel 20 and/or irrigantpressure line 22 can flow through the valve channel 228. Flow from thepump 8 to the exhaust port 144 can be blocked by the first valve 208.The irrigant delivery pressure can be turned on completely or partially.The irrigant delivery pressure can be, for example, from about 80 mm Hg(1.5 psi) to about 120 mm Hg (2.32 psi).

The second valve 224 can have multiple configurations, similar to thefirst and second configurations shown for the first valve 208 in FIGS.42 and 43. For example, the second valve 224 can have a firstconfiguration to direct flow to the pump 8 from the aspirant pressureline 18 or to the pump 8 from the intake port 152.

The first valve 208 and/or the second valve 224 can be manually orautomatically controlled. The first 208 and/or second valves 208 can bebimodal (e.g., on or off positions only), multimodal (e.g., fixed finitevalve settings), analog (e.g., substantially infinite variability ofvalve settings), or a combination thereof.

FIG. 44 illustrates that the device 2 can have a first pump 230 and asecond pump 232. The first pump 230 and/or second pump 232 can be manualor automatic (e.g., driven by an electric motor). For example the firstpump 230 can be automatic and the second pump 232 can be manual,spring-loaded piston pump with a one-way valve, as shown. The first pump230 can provide aspirant suction pressure to the aspirant pressure line18. The outgoing pressure from the first pump 230 can be exhaustedthrough the exhaust port 144.

The second pump 232 can be in the irrigant channel 24. The second pump232 can pressurize the irrigant 57 in the irrigant channel 24. Thesecond pump 232 can be pumped, as shown by arrow, for example by hand(e.g., with a thumb on a button). The second pump 232 can be actuated bya thumb 42 on a button 34 on the body 4 of the device 2. The irrigant 57can be atomized, as shown, upon exiting the atomization port 46. Theirrigant 57 can be delivered from the nozzle 59 in a non-atomized streamor spray.

The pumps 8 can have bellows.

The first pump 230 can produce a different or the same flow rate and/orpressure as the second pump 232.

FIG. 45 illustrates that the head 14 can have a longitudinal head axis234. The body 4 can have a longitudinal body axis 236 aligned with thehead-end of the body 4. The head axis 234 can be aligned with the bodyaxis 236, for example, when the head 14 is in a relaxed configurationand/or when the neck 12 is in a relaxed configuration.

FIG. 46 illustrates that the head 14 can be rotated to a non-zero andpositive head angle 238. The head angle 238 can be the angle from thebody axis 236 to the head axis 234. The head angle 238 between the headaxis 234 and the body axis 236 can be from about −180° to about +180°(e.g., the head 14 can have about 360° of rotational motion in oneplane), for example about +35°, or 0°, or −35° (e.g., the head 14 canhave about 70° of rotational motion in one plane). The neck 12 can beconfigured to deform to the rotated head angle 238. The neck 12 canresiliently reset to a preset head angle 238 (e.g., 0°) when a rotatingforce on the head 14 is removed.

FIG. 47 illustrates that the head 14 can be rotated to a negative headangle 238.

FIG. 48 illustrates that the head 14 can rotate, as shown by arrow 312,around the body 4. For example, the head axis 234 can rotate around thebody axis 236. The neck 12 can rotate the head 14 around the body 4.

The oscillations or vibrations of the device (e.g., due to pump motors,reciprocating solenoids, piezoelectric transducers) can be dampened.Actuators, pumps 8, valves 10 and other moving parts can be mounted tothe body 4, neck 12 or head 14 using dampers, such as soft rubberwashers. Excessive pressure and pump exhausts can be muffled, forexample using a restricting plate in an exhaust conduit 140 or port 144.The walls of the device 2 can be thickened and made from layered and/orlaminated materials. The walls of the device 2 can be otherwisesound-proofed. Moving parts in the device 2 can be dynamically balanced,for example such that all support forces sum to zero at any giveninstant and/or the device 2 can have active noise cancellation. Motors(e.g., in the pumps) can have counterbalances. Multiple motors can beconfigured to oppose dynamic forces.

Any of the valves 10 herein can be flow diodes, such as check valves 10.Any of the valves 10 herein can be ball valve, swing valve, clappervalve, umbrella valve, double check valve, duck bill valve 70, orcombinations thereof.

The device 2 can be configured at full power to aspirate, for example,up to about 20,000 cc/min. (1,220 in³/min.) of air with no flowrestriction. The device 2 can be configured to at full power to producean aspiration suction with no flow, for example, up to about 100 mmHg (2psi). The device 2 can be configured at full power to irrigate up toabout 1.5 cc/min. (9.2 in³/min.) of irrigant 57 with no flowrestriction.

The device 2 can be configured to be portable. For example, the device 2can be unattached to any external devices (e.g., a wall or floor-mountedoutlet or source for power, pressure, irrigant, or the aspirantreservoir).

The device 2 can be configured to be handheld. For example, the device 2can weigh less than about 5.0 kg (11 lbs.), more narrowly less thanabout 2.0 kg (4.4 lbs.), more narrowly less than about 1.0 kg (2.2lbs.). The device 2 can have a total maximum diameter less than about 41cm (16 in.), more narrowly less than about 30 cm (12 in.), yet morenarrowly less than about 25 cm (10 in.).

The device 2 can be used to deliver therapeutic drugs, and/or saline,and/or diagnostic agents, and/or antiseptic agents. The device 2 can beused to delivery drugs to the lungs.

The device 2 can have one, two or more buttons 34, rocker switches, orother elements to control the aspirant suction pressure and/or irrigantdelivery pressure. The buttons 34 (or other elements) can be used toactivate electronics (e.g., the pump motor, microprocessor), valves,manually pump, or combinations thereof.

The terms aspiration and aspirant are used interchangeably herein whenused as descriptors for elements (e.g., aspiration reservoir 56 andaspirant reservoir 56). The terms irrigation and irrigant are usedinterchangeably herein when used as descriptors for elements. The termsatomizing and atomization are used interchangeably herein when used asdescriptors for elements.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The above-described configurations,elements or complete assemblies and methods and their elements forcarrying out the invention, and variations of aspects of the inventioncan be combined and modified with each other in any combination.

We claim:
 1. A portable, handheld device for irrigating with an irrigantand aspirating biological tissue and/or secretions comprising: a body; afirst neck; a first head connected to the body, wherein the first headcomprises a compliant outer surface configured to seal against anostril, and wherein the first head is configured to be detached fromthe body; a first port in the first head; an irrigant reservoir indirect fluid communication with the first port, and wherein the firstport is configured to deliver an irrigant to outside of the head; afirst channel in the first head, wherein the first channel terminates atthe first port; a second port configured to receive an aspirant fromoutside of the first head; a second channel in the first head, whereinthe second channel terminates at the second port, and wherein the firstchannel is to one side of the second channel; an aspirant reservoir indirect fluid communication with the second port; and a fluid controlsystem comprising a pump, wherein the fluid control system is configuredto control an irrigation delivery pressure of the irrigant outside ofthe first head, and wherein the fluid control system is configured tocontrol an aspiration pressure into the first head.
 2. The device ofclaim 1, wherein the fluid control system is configured to control theaspiration pressure concurrent with the irrigation delivery pressure. 3.The device of claim 1, further comprising an irrigant reservoir seal ona side of the first head.
 4. The device of claim 3, wherein the irrigantreservoir is in fluid communication with the irrigant reservoir seal. 5.The device of claim 4, wherein the first head and first neck areconfigured to be detached together from the remainder of the device. 6.The device of claim 5, further comprising a second head and second neck,wherein the second head and second neck are configured to be attached tothe remainder of the device in place of the first head and first neckafter the detachment of the first head and first neck.
 7. The device ofclaim 1, wherein the first neck is configured to articulate.
 8. Thedevice, of claim 1, wherein the first channel has a first axis, andwherein the second channel has a second axis, and wherein an extensionof the first axis distal to a terminus of the first channel intersectsan extension of the second axis distal to a terminus of the secondchannel.
 9. The device of claim 1, wherein at least a length of thefirst channel is nonparallel with at least a length of the secondchannel.
 10. A portable, handheld device for irrigating with an irrigantand aspirating biological tissue and/or secretions comprising: a body; afirst neck; a first head connected to the body, wherein the first headcomprises a compliant outer surface configured to seal against anostril, and wherein the first head is configured to be detached fromthe body; a first port in the first head; an irrigant reservoir indirect fluid communication with the first port, and wherein the firstport is configured to deliver an irrigant to outside of the head; afirst channel in the first head, wherein the first channel terminates atthe first port; a second port configured to receive an aspirant fromoutside of the first head; a second channel in the first head, whereinthe second channel terminates at the second port, and wherein at least alength of the first channel is nonparallel with at least a length of thesecond channel; an aspirant reservoir in direct fluid communication withthe second port; and a fluid control system comprising a pump, whereinthe fluid control system is configured to control an irrigation deliverypressure of the irrigant outside of the first head, and wherein thefluid control system is configured to control an aspiration pressureinto the first head.
 11. The device of claim 10, wherein the fluidcontrol system is configured to control the aspiration pressureconcurrent with the irrigation delivery pressure.
 12. The device ofclaim 10, further comprising an irrigant reservoir seal on a lateralside of the first head.
 13. The device of claim 10, wherein the irrigantreservoir is in fluid communication with the irrigant reservoir seal.14. The device of claim 13, wherein the first head and first neck areconfigured to be detached together from the remainder of the device. 15.The device of claim 14, further comprising a second head and secondneck, wherein the second head and second neck are configured to beattached to the remainder of the device in place of the first head andfirst neck after the detachment of the first head and first neck. 16.The device of claim 10, wherein the first neck is configured toarticulate.
 17. The device of claim 10, wherein the first channel has afirst axis, and wherein the second channel has a second axis, andwherein an extension of the first axis distal to a terminus of the firstchannel intersects an extension of the second axis distal to a terminusof the second channel.
 18. A portable, handheld device for irrigatingwith an irrigant and aspirating biological tissue and/or secretionscomprising: a body; a first neck; a first head connected to the body,wherein the first head comprises a compliant outer surface configured toseal against a nostril, and wherein the first head is configured to bedetached from the body; a first port in the first head; an irrigantreservoir in direct fluid communication with the first port, and whereinthe first port is configured to deliver an irrigant to outside of thehead; a first channel in the first head, wherein the first channelterminates at the first port; a second port configured to receive anaspirant from outside of the first head; a second channel in the firsthead, wherein the second channel terminates at the second port, andwherein the first channel has a first axis, and wherein the secondchannel has a second axis, and wherein an extension of the first axisdistal to a terminus of the first channel intersects an extension of thesecond axis distal to a terminus of the second channel; an aspirantreservoir in direct fluid communication with the second port; and afluid control system comprising a pump, Wherein the fluid control systemis configured to control an irrigation delivery pressure of the irrigantoutside of the first head, and wherein the fluid control system isconfigured to control an aspiration pressure into the first head. 19.The device of claim 18, wherein the fluid control system is configuredto control the aspiration pressure concurrent with the irrigationdelivery pressure.